Steridrolo

Package leaflet: Information for the user

STERIDROLO 2.5 g powder for solution in water, 5 g powder for solution in water

Chloramine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if you notice worsening of symptoms after a few days.

Contents of this leaflet:

1. What Steridrolo is and what it is used for
2. What you need to know before you use Steridrolo
3. How to use Steridrolo
4. Possible side effects
5. How to store Steridrolo
6. Contents of the pack and other information

1. What Steridrolo is and what it is used for

Steridrolo contains the active substance chloramine, which belongs to a group of medicines called antiseptics and disinfectants that prevent the growth of bacteria, fungi, viruses, and other microorganisms. In addition, this medicine promotes wound healing when applied to injuries.
Steridrolo is indicated for:

• disinfecting and cleaning the skin in case of minor superficial wounds, mild pressure ulcers (i.e. affecting only the most superficial layer of the skin), minor and non-extensive burns (first-degree burns);
• disinfecting the external genitalia.

Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you should know before using Steridrolo

Do not use Steridrolo if:

• you are allergic to chloramine or similar substances (chlorine-releasing substances).

Warnings and precautions
Talk to your doctor or pharmacist before using Steridrolo.
Do not swallow. This medicine is for external use only. Accidental ingestion of the disinfectant solution may lead to serious, sometimes fatal, consequences.
Avoid contact with the eyes. The use, especially if prolonged, of topical products may give rise to sensitization reactions; if this occurs, discontinue treatment and consult your doctor.

Other medicines and Steridrolo
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
This includes also medicines without a prescription. This is because Steridrolo may affect how some medicines work, or because other medicines may affect how Steridrolo works.
Do not use Steridrolo together with other medicines used for disinfection and cleansing.

Fertility, pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
This medicine does not affect, or has a negligible effect on, the ability to drive vehicles or operate machinery.

3. How to use Steridrolo

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Disinfection of injured skin
2.5 g sachets: The recommended dose is 2 sachets dissolved in half a litre of water.
5 g sachets: The recommended dose is 2 sachets dissolved in 1 litre of water.

Disinfection of external genitalia
2.5 g sachets: The recommended dose is 1 sachet dissolved in 1 litre of water.
5 g sachets: The recommended dose is 1 sachet dissolved in 2 litres of water.

Repeat the disinfection 2–3 times a day or as prescribed by your doctor.
Do not exceed the recommended doses.

If you use more Steridrolo than you should
If you have used more Steridrolo than you should, speak to a doctor or go to hospital immediately. Take the medicine pack with you.

Accidental ingestion of the disinfectant solution may lead to serious consequences, which may be fatal.

In case of accidental ingestion/overdose of Steridrolo, after inducing vomiting, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur are listed below:

• eye irritation;
• medicine intolerance, characterised by burning or irritation, which does not require treatment modification.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Steridrolo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
• Store below 30 °C.
• After preparing the solution for use, keep it tightly closed and protected from light. The prepared solution is stable for 3 months.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Steridrolo contains
Steridrolo powder for solution in water, 2.5 g sachets

• The active substance is chloramine. Each sachet contains 2.5 g of chloramine (equivalent to 0.625 g of active chlorine).

Steridrolo powder for solution in water, 5 g sachets

• The active substance is chloramine. Each sachet contains 5 g of chloramine (equivalent to 1.25 g of active chlorine).

Description of the appearance of Steridrolo and contents of the pack
Steridrolo powder for solution in water, 2.5 g sachets
Pack of 12 sachets of 2.5 g.
Steridrolo powder for solution in water, 5 g sachets
Pack of 10 sachets of 5 g.

Marketing Authorization Holder
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri, 50018
Scandicci (FI)

Manufacturers
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri, 50018
Scandicci (FI)
Sigmar Italia SpA, Via Sombreno 11, Almè (BG)